Isis Begins Clinical Tests for Obesity Drug

Friday, December 23, 2011

Carlsbad-based Isis Pharmaceuticals Inc. has launched Phase 1 clinical studies for a drug that aims to help severely obese people lose weight without interacting with the brain or heart, the company said on Dec. 20.

The drug, which the company is calling ISIS-FGFR4Rx, decreases the body’s ability to store fat while also boosting fat-burning mechanisms.

“Obesity is an epidemic in the United States and much of the rest of the industrialized world,” Richard Geary, senior vice president of development at Isis, said in a company statement. “Severely obese patients make up the most rapidly growing part of the obese population. In these severely obese patients, bariatric, or weight-loss, surgery is a preferred therapeutic option; however long-term weight loss remains a challenge for these patients.”

He said that many obesity therapies in development or on the market have “unacceptable safety profiles” because they interact with the brain and central nervous system to suppress appetite. The Isis drug, on the other hand, targets the liver and fat tissues, and “should not produce any CNS effects,” the company said.

“Clearly there is a significant need for a treatment approach that can cause weight loss without deleterious side effects,” Geary said.

In preclinical studies on obese animals, the drug resulted in “robust and sustained weight reduction,” and an improvement in insulin sensitivity, said Sanjay Bhanot, Isis’ vice president of clinical development and translational medicine. Isis also tested the drug in combination with appetite-suppressing therapies, he said.

Isis developed the drug using its so-called “antisense” technology platform, which creates small compounds that are chemically modified to precisely interact with RNA molecules and inhibit the production of disease-causing proteins.

The company has a broad pipeline of drugs in development to treat a range of diseases, from cancer to blood clotting disorders. Isis shares, which trade on Nasdaq as ISIS, closed Dec. 22 at $7.00, down almost 1 percent from the previous day’s closing price.